Dry Eye Disease, Sjögren Syndrome
Conditions
Keywords
oligonucleotide, siRNA, keratoconjunctivitis sicca, SYL1001
Brief summary
This study will examine the efficacy and safety of tivanisiran sodium eye drops versus vehicle after a 2-week run-in phase when dosed once daily for 3 months in subjects with signs and symptoms of dry eye disease (DED) due to Sjögren's Syndrome.
Interventions
1 drop in the affected eye(s) once daily
DRUGVehicle ophthalmic solution
1 drop in the affected eye(s) once daily
Sponsors
Sylentis, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is a male or a female aged ≥ 18 years * Have given their written consent to participate in the study * Use of artificial tears (AT), autologous serum or specific dry eye medications during the last 6 months prior to the selection * Willing to not use AT or autologous serum for the study duration * VAS scale for Dry Eye Symptom Score ≥ 40 * Total CFS ≥ 5 * Schirmer's test with anesthesia \< 10 mm/5min * Patients with Sjögren Syndrome
Exclusion criteria
* Any concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications at the time of entry into the study * Use of contact lenses during the study * Significant Eye diseases according to investigator's opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening. | 85 days |
| Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening. | 85 days |
Countries
Spain, United States
Outcome results
None listed